Institutional Review Board
Human Research Protection Program
1 Park Avenue | 6th Floor | New York, NY 10016
http://irb.med.nyu.edu
Application for Waiver of Authorization and/or Consent
Submission Instructions
Our website provides full instructions on submitting applications to the IRB: http://irb.med.nyu.edu/esubmission
Please contact the IRB office at 212 263-4110 with any questions.
Administrative Information
Study#
-
Date of this request
Study Title
Role
Name
Kerberos
ID/Email**
Phone
Fax
Principal Investigator
Contact Person
Request
In order to access or use an individual’s Protected Health Information (PHI) in the conduct of research without
the express authorization of the individual, you must request a waiver of authorization.
In order to conduct research without the express written consent of a human subject, you must request a
waiver of informed consent.
You may also request an alteration in consent or authorization. In other words: you will be obtaining written
consent but may require certain elements of the consent be altered and you will need to request an alteration
in consent and authorization.
You may request a waiver of documentation of consent. There are required elements that must be met, but a
waiver of documentation of consent means that you will obtain consent, but you do not use an informed
consent document.
Indicate the nature of this
request
Does this research present no
more than Minimal Risk of
harm to subjects
waiver of authorization (complete I and III)
alteration or waiver of consent (complete II.A, II.B & III)
waiver of documentation of consent (complete II.A, II.C & III)
Yes; Explain:
No; STOP: This study is not eligible for an Alteration or Waiver of Authorization or
Consent or a Waiver of Documentation of Consent
I. Authorization
Fill this out if you seek to obtain a waiver of authorization to use and disclosures protected health information.
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Application for Waiver of Authorization and/or Consent
NYU School of Medicine IRB HRPP
A. Record/Specimen Use
Check the boxes of the items that will be used
Indicate your study’s source(s)
of health information
physician/clinic records
interviews/questionnaires
mental health records
billing records
lab, pathology and/or radiology results
biological samples obtained from the subjects
hospital/medical records (in- and out-patient)
data previously collected for research purposes
other; specify:
B. Protected Health Information
Describe the PHI being used
or disclosed in your study
Patient/subject name
Address street location
Address town or city
Address state
Address zip code
Elements of dates (except year) related to an individual. (ie. DOB,
admission/discharge dates, date of death)
Telephone number
Fax number
Electronic mail (email) address
Social security number
Medical record numbers
Health plan beneficiary numbers
Account numbers
Certificate/license numbers
Vehicle identification numbers and serial numbers including license plates
Medical device identifiers and serial numbers
Web URLs
Internet protocol (IP) address
Biometric identifiers (finger and voice prints)
Full face photographic images
Any unique identifying number, characteristic or code (a rare disease can be
considered a unique id)
Link to identifier (code)
C. Request for Waiver of Authorization
If any box in section I.B above
is checked, list every
investigator, research staff
member or other staff member
who will have access to this
data
Describe the risks to privacy
involved in this study and
explain why the study involves
no more than minimal risk to
privacy
Describe investigator’s plan to
protect identifiers from
improper use or disclosure and
to destroy them at the earliest
time
Explain why it is not possible to
seek subjects’ authorization for
use or disclosure of the PHI
Explain why it is not possible to
conduct this research without
use or disclosure of the PHI
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Application for Waiver of Authorization and/or Consent
NYU School of Medicine IRB HRPP
II. Informed Consent
Complete II.A and II.B if you are seeking an alteration or complete waiver of your research subject’s right to
informed consent.
Complete II.A and II.C if you are seeking a waiver of documentation of informed consent.
A. Overview
Briefly explain the consent
process for your study
B. Alteration or Waiver of Informed Consent
Describe the possible risks of
harm to the subjects involved
in this study and explain why
the study involves no more
than minimal risk to subject
Explain why the
waiver/alteration will not
adversely affect the rights and
welfare of the subjects
Explain why it is impracticable
to conduct this research if
informed consent is required
Explain, if appropriate, how the
subjects will be provided with
additional pertinent information
after participation.
If not appropriate, explain why
C. Waiver of Documentation of Informed Consent
For this subsection, complete either Subsection 1 or 2
Subsection 1
(a) The only record linking the
Yes; explain:
* note you MUST have completed Section I.B (above)
subject to the research will be
No;
not
eligible
for
waiver under this section
the consent document
(b) Would the principal risk
Yes; explain:
would be potential harm
resulting from a breach in
No
confidentiality
(c) Will subjects be provided
Yes; Attach document for IRB Review and Approval
with a written statement
No explain:
regarding the research*
*to proceed with a waiver meeting the above criteria, each subject must be asked whether they wish documentation linking them to your
study. You must include this in your description of the consent process in II.A (above) and in your protocol.
Subsection 2
(a) Describe the possible risks
of harm to the subjects
involved in this study and
explain why the study involves
no more than minimal risk to
subject
(b) The research involves no
procedures for which written
consent is normally required
outside the research context
(c) Will subjects be provided
with a written statement
regarding the research*
Yes; explain:
No; not eligible for waiver under this section
Yes; Attach document for IRB Review and Approval
No explain:
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Application for Waiver of Authorization and/or Consent
NYU School of Medicine IRB HRPP
*to proceed with a waiver meeting the above criteria, each subject must be asked whether they wish documentation linking them to your
study. You must include this in your description of the consent process in II.A (above) and in your protocol.
III. Signatures
Principal Investigator’s Signature
Date
Print Name
Signature
I assure the IRB that the protected health information which I have detailed in this Waiver of
Authorization and/or Consent application will not be reused (i.e.: used other than as described in this
application) or disclosed to any person or entity other than those listed above, except as required by
law, for authorized oversight of this research study, or as specifically approved for use in another
study by the NYU SoM IRB.
I also assure the NYU SoM IRB that the information that I provide in this application is accurate and
complete, and that the PHI that I request is the minimum amount of identifiable health information
necessary for my research project.
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